NCT03645187

Brief Summary

The study aimed at evaluation of anticancer effect of celecoxib as adjuvant therapy to chemotherapy in patients with metastatic colorectal cancer

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2018

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

7 years

First QC Date

August 22, 2018

Last Update Submit

April 16, 2021

Conditions

Colon Cancer Stage

Outcome Measures

Primary Outcomes (1)

  • number of patients with improved radiology

    number of patients with improved radiology

    6 months

Study Arms (2)

FOLFERI

ACTIVE COMPARATOR

FOLFERI regien

Drug: FOLFERI

FOLFERI and celecoxib

ACTIVE COMPARATOR

FOLFERI and celecoxib

Drug: Folferi and celecoxib

Interventions

FOLFERIDRUG

FOLFERI regimen

FOLFERI
Folferi and celecoxibDRUG

Folferi regimen and celecoxib

FOLFERI and celecoxib

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • advanced colorectal cancer

You may not qualify if:

  • cerebral metastases
  • other malignancy
  • H pylori infection
  • thromboembolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amira Roushdy

Tanta, Elgharbia, 35111, Egypt

RECRUITING

Related Publications (1)

  • Mostafa TM, Alm El-Din MA, Rashdan AR. Celecoxib as an adjuvant to chemotherapy for patients with metastatic colorectal cancer: A randomized controlled clinical study. Saudi Med J. 2022 Jan;43(1):37-44. doi: 10.15537/smj.2022.43.1.20210574.

    PMID: 35022282DERIVED

MeSH Terms

Interventions

Celecoxib

Intervention Hierarchy (Ancestors)

BenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Tarek M Mostafa, Prof

    Clinical pharmacy Department- Tanta University

    PRINCIPAL INVESTIGATOR

  • Mohamed Alm El-din, prof

    Clinical Oncology - Tanta University

    STUDY DIRECTOR

  • Amira Roushdy, Msc

    Clinical pharmacy Department- Tanta University

    STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, MD

CONTACT

00201147773440sheriefabdelsalam@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhDTropical Medicine

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

August 1, 2018

Primary Completion

August 1, 2025

Study Completion

December 1, 2025

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)